Strattera

[atomoxetine HCl]

Warnings & Precautions
WARNINGS

Allergic Events

Although uncommon, allergic reactions, including angioneurotic edema, urticaria, and rash, have been reported in patients taking STRATTERA.

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Growth

Growth should be monitored during treatment with STRATTERA. During acute treatment studies (up to 9 weeks), STRATTERA-treated patients lost an average of 0.4 kg, while placebo patients gained an average of 1.5 kg. In a controlled trial that randomized patients to placebo or 1 of 3 atomoxetine doses, 1.3%, 7.1%, 19.3%, and 29.1% of patients lost at least 3.5% of their body weight in the placebo, 0.5, 1.2, and 1.8 mg/ kg/ day STRATTERA dose groups, respectively.

During acute treatment studies, STRATTERA-treated patients grew an average of 0.9 cm, while placebo-treated patients grew an average of 1.1 cm. There are no long-term, placebo-controlled data to evaluate the effect of STRATTERA on growth. Weight and height were assessed during open-label studies of 12 and 18 months, and mean rates of growth were compared with normal growth curves. Patients treated with STRATTERA for at least 18 months gained an average of 6.5 kg while mean weight percentile decreased slightly from 68 to 60. For this same group of patients, the average gain in height was 9.3 cm with a slight decrease in mean height percentile from 54 to 50.

Among patients treated for at least 6 months, mean weight gain was lower for poor metabolizer (PM) patients compared with extensive metabolizer (EM) patients (+ 0.7 kg compared with +3.0 kg), while mean growth for PM patients was 4.3 cm and mean growth for EM patients was 4.4 cm. Whether final adult height or weight is affected by treatment with STRATTERA is unknown. Patients requiring long-term therapy should be monitored and consideration should be given to interrupting therapy in patients who are not growing or gaining weight satisfactorily.

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